Phase II Clinical Trial to Investigate the Efficacy, Safety and Pharmacokinetics of YH14617 After Once Weekly or Biweekly Administration in Patients With Type 2 Diabetes Mellitus

Brief Summary

The objective of this study is to assess the safety, efficacy and pharmacokinetic of YH14617 after once weekly or biweekly injection in patients with type 2 Diabetes Mellitus to investigate the optimal recommended dosage. Study period is 20 weeks including 12 weeks of treatment period and 8weeks of follow-up period without treatment.

* Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ICMJE

Completed

Enrollment ICMJE

84

Completion Date

February 2015

Primary Completion Date

January 2015 (final data collection date for primary outcome measure)

Eligibility Criteria ICMJE

Inclusion Criteria:

Have signed a written informed consent voluntary, prior to the any procedure

Volunteers of aged between 20 years to 75 years

Have been diagnosed with type 2 diabetes at least 3 months prior to study

Have a body mass index (BMI) of > 23kg/m2 and have a history of stable body weight during 3 months prior to the first administration (not varying by > 5% in weight)

Have been treated with stable dose regimen of Metformin > 1500mg/day or maximum tolerant dose for at least 3 months prior to the first administration

Have an HbA1c between 7% and 10% inclusive

Exclusion Criteria:

Have been treated with insulin, sulfonylurea, thiazolidinedione class hypoglycemic drugs, exenatide or other GLP-1 receptor agonist, DPP4-inhibitor, glucocorticoid and drugs that promote weight loss within 3 months prior to the first administration

Have acute disease, other untreated disease or diabetic complications that needs additional treatment